Needle mechanism module for drug delivery device

ABSTRACT

A needle mechanism module for automatically inserting a fluid path into a patient for drug delivery is provided. The needle mechanism module can be a component of a wearable drug delivery device. The needle mechanism module can insert a needle and cannula into the patient responsive to activation of the drug delivery device by a user. After insertion, the needle can be automatically retracted, leaving only the cannula in the patient. As a result, discomfort of the user is reduced.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional applicationSer. No. 16/140,178, filed Sep. 24, 2018, which claims the benefit ofU.S. Provisional Application No. 62/563,327, filed Sep. 26, 2017, thecontents of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

Embodiments generally relate to medication delivery. More particularly,embodiments relate to automatic insertion of a fluid path component intoa patient for drug delivery.

BACKGROUND

Conventional on-body or wearable drug delivery devices (e.g., infusiondevices or pumps) often require manual insertion of a needle into theuser to provide a fluid path from a liquid drug stored in the drugdelivery device to the user. Many users dislike the manual needleinsertion required by these conventional drug delivery devices. Further,many users may not insert the needle properly, thereby leading toinefficient or improper use of the conventional drug delivery device.

Accordingly, there is a need for a drug delivery device that providesfor automatic insertion of a fluid path component into the user thatreduces the discomfort of the user while preventing any user error.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a first cross-sectional side view of an exemplaryneedle mechanism module.

FIG. 2 illustrates an exploded view of a portion of the needle mechanismmodule depicted in FIG. 1.

FIG. 3 illustrates an overhead side view of the needle mechanism moduledepicted in FIG. 1.

FIG. 4 illustrates a first side view of the needle mechanism moduledepicted in FIG. 1.

FIG. 5 illustrates a second side view of the needle mechanism moduledepicted in FIG. 1.

FIG. 6 illustrates a third side view of the needle mechanism moduledepicted in FIG. 1.

FIG. 7 illustrates a fourth side view of the needle mechanism moduledepicted in FIG. 1.

FIG. 8 illustrates a second cross-sectional side view of the needlemechanism module during insertion of a needle and a cannula.

FIG. 9 illustrates a third cross-sectional side view of the needlemechanism module during insertion of the needle and the cannula.

FIG. 10 illustrates a fourth cross-sectional side view of the needlemechanism module during retraction of the needle.

FIG. 11 illustrates a fifth cross-sectional side view of the needlemechanism module during retraction of the needle.

FIG. 12 illustrates a sixth cross-sectional side view of the needlemechanism module after retraction of the needle.

FIG. 13 illustrates an overhead side view of the needle mechanism moduledepicted in FIG. 12.

FIG. 14 illustrates a first component of the needle mechanism module.

FIG. 15 illustrates a second component of the needle mechanism module.

FIG. 16 illustrates a front view of various components of the needleinsertion mechanism.

FIG. 17 illustrates a side view of the various components of the needleinsertion mechanism depicted in FIG. 16.

FIG. 18 illustrates an angled view of the various components of theneedle insertion mechanism depicted in FIG. 16.

FIG. 19 illustrates a method of operation for the needle mechanismmodule depicted in FIG. 1.

DETAILED DESCRIPTION

This disclosure presents various systems, components, and methodsrelated to a drug delivery device and, in particular, a needle mechanismmodule for automatically inserting and retracting a needle. Each of thesystems, components, and methods disclosed herein provides one or moreadvantages over conventional systems, components, and methods.

Various embodiments include a needle mechanism module for automaticallyinserting a needle and a cannula into a patient or user and retractingthe needle, thereby leaving the cannula in the patient for the deliveryof a drug from a wearable or on-body drug delivery device of which theneedle mechanism module can be a component.

In various embodiments, the needle mechanism module can insert a fluidpath component or portion thereof into a patient automatically for drugdelivery. In an on-body delivery system (e.g., a wearable drug deliverysystem), automatic insertion of the fluid path component into thepatient can reduce fear and/or pain that may be experienced by the userand may also minimize user error. The needle mechanism module canfurther improve patient comfort by retracting the introducer needle andleaving only a soft cannula in the patient. In various embodiments, theneedle is never seen by the patient, as it is initially inside the drugdelivery device and automatically retracts back into the device uponinsertion. The quick action of a spring-loaded insertion mechanism canminimize the amount of time the needle is in the patient and maydecrease pain as compared with a manual insertion of a needle. Further,retraction of the needle back into the device provides sharps protectionwhen the drug delivery device is removed from the user. The needlemechanism module can be provided as a standalone component, and so ishighly transferable for use in different device designs. Otherembodiments are disclosed and described.

FIG. 1 illustrates a needle mechanism or needle mechanism module 100.The needle mechanism module 100 can be a component or part of a drugdelivery device such as, for example, an on-body or wearable drugdelivery device. The needle mechanism module 100 can automaticallyinsert a fluid path component into a patient to facilitate drugdelivery. In various embodiments, the needle mechanism module 100 caninsert and retract an introducer needle and can leave a soft cannula inthe patient. The soft cannula and retracted introducer needle can form aportion of the fluid path component coupling a liquid drug stored withinthe drug delivery device to the patient.

FIG. 1 shows a side cross-sectional view of the needle mechanism module100. As shown in FIG. 1, the needle mechanism module 100 can include arail housing component 102, a slide insert component 104, a slideretract component 106, a hard stop component 108, an insert spring 110,a retract spring 112, a tension lock component 114, a needle 116, acannula 118, a lock component 120, and a rail beam component 126. FIG. 1illustrates the needle mechanism module 100 prior to activation. Thatis, FIG. 1 illustrates the needle mechanism module 100 in an initialoperational state prior to insertion and retraction of the needle 116.

As shown in FIG. 1, the slide insert 104 and the slide retract 106 arecoupled together and spaced apart from the hard stop 108. The hard stop108 can be positioned at a first end of the rail 102. The slide insert104 and the slide retract 106 can be positioned at a second, oppositeend of the rail 102. The position of the hard stop 108 can be fixed. Theslide insert 104 and the slide retract 106 can move along and within therail 102 when not locked to the position shown in FIG. 1 as describedfurther herein. The insert spring 110 can be an extension spring. Theinsert spring 110 can be coupled to the hard stop 108 and to the slideinsert 104. The insert spring 110 can be configured to be biased so asto draw or bring the slide insert 104 and the slide retract 106 towardthe hard stop 108. The lock 120 can be configured to prevent the insertspring 110 from moving the slide insert 104 and the slide retract 106toward the hard stop 108. As shown in FIG. 1, the lock 120 can becoupled to or positioned adjacent to a portion of the slide insert 104.The arrangement of the lock 120 and the slide insert 104 as shown inFIG. 1 can prevent or block the slide insert 104 (and the coupled slideretract 106) from moving toward the hard stop 108. The rail beam 126, asfurther described herein, can be coupled to the rail 102 and canrestrict downward movement of the tension lock 114 as described herein.

As shown in FIG. 1, the needle 116 (e.g., an introducer needle) and thecannula 118 (e.g., a soft cannula) can be coupled to the slide insert104. The needle 116 can be positioned inside of the cannula 118 suchthat the cannula 118 fits over and around a portion of the needle 116.The slide insert 104 can include a pocket 122. An end portion or nailhead 124 of the cannula 118 can be positioned within the pocket 122. Theend portion or nail head 124 of the cannula 118 and the pocket 122 canbe configured to hold or retain the cannula 118. The needle 116 canextend beyond the slide retract 106 as shown. A portion of the needle116 that extends beyond the slide retract 106 can be a service loop ofthe needle 116. The service loop of the needle 116 can allow the needle116 to move forward for insertion (e.g., the service loop of the needle116 can provide slack for when the needle 116 moves forward in adirection toward the hard stop 108 during insertion). The needle 116 canbe coupled to a liquid drug or other therapeutic agent stored by awearable drug delivery device (e.g., stored in a reservoir). The needle116 and the cannula 118 can form the fluid path component (or a portionthereof) coupling the liquid drug to the patient. The stored liquid drugcan be provided to a patient by way of the needle 116 and the cannula118 as described further herein.

FIG. 2 illustrates an exploded view of a portion of the needle mechanismmodule 100 depicted in FIG. 1. The needle 116 and the cannula 118 arenot shown in FIG. 2 for simplicity and clarity. FIG. 2 shows thearrangement of the constituent components of the needle mechanism module100 described in relation to FIG. 1.

Referring to FIGS. 1 and 2, the hard stop 108 can be attached to a firstend of the rail 102. The rail 102 can have an open center area toaccommodate the other components of the needle mechanism module 100.When not locked into the position shown in FIG. 1, the slide insert 104and the slide retract 106 can move along the open area of the rail 102toward the hard stop 108. The spring 110 can be coupled to the hard stop108 and the slide insert 104. The tension lock component 114 can bepositioned to couple the slide insert 104 to the slide retract 106.Specifically, a first end of the tension lock component 114 can attachedor coupled to a center portion of the slide insert 104 and a second,opposite end of the tension lock component 114 can extend beyond theslide retract 106. The second end of the tension lock component 114 canbe larger than the portion of the tension lock component 114 thatconnects the first and second ends of the tension lock component 114.The increased size of the second end of the tension lock component 114,in conjunction with the connection of the first end to the slide insert104, can keep the slide inset 104 and slide retract 106 coupled closelytogether as shown.

A portion of the spring 110 can be positioned around the center portionof the slide insert 104. A portion of the center portion of the slideinsert 104 can be open along with a portion of a center portion of theslide retract 106. The spring 112 can be positioned within these openareas of the slide insert 104 and the slide retract 106 as shown. Thespring 112 can be a compression spring. The tension lock component 114and the rail beam 126 can be positioned within these open areas as well.The spring 112 can be positioned around the tension lock component 114and the rail beam 126 as shown.

FIG. 3 illustrates an overhead side view of the needle mechanism module100 as depicted in FIG. 1. FIG. 3 furthers shows the arrangement of theconstituent components of the needle mechanism module 100 described inrelation to FIG. 1. As shown in FIG. 3, the needle 116 can be routedthrough the slide retract 106 and can extend beyond the slide retract106. The needle 116 can be shaped as desired to be routed through thedrug delivery device to be coupled to the stored liquid drug (e.g., toan outlet of a reservoir storing the liquid drug). Further, the needle116 can be wrapped around a notch or other feature in the slide retract106 to allow it to move with the slide retract 106.

Referring to FIGS. 1 and 3, the cannula 118 is positioned around aportion of the needle 116. The nail head 124 of the cannula 118 isdirectly attached to the slide insert 104. The needle 116 is routedthrough this portion of the cannula 118 and through the slide insert104. Accordingly, in various embodiments, the needle 116 is not directlyattached to the slide insert 104. The needle 116 can be directlyattached to the slide retract 106 (e.g., attached to a notch or othercoupling between the slide retract 106 and the needle 116). Thisarrangement of components and routing of the needle 116 relative to thecannula 118 allows the needle 116 and the cannula 118 to both movetogether toward the hard stop 108 as the slide insert 104 and the slideretract 106 both move toward the hard stop 108 as further describedherein. Further, this arrangement of components and routing of theneedle 116 relative to the cannula 118 allows the cannula 118 to be heldin a fixed, stationary position when the slide insert 104 is held in afixed position as the slide retract 106 is moved back away from the hardstop 108, which causes the needle 116 to also move with the slideretract 106 and therefore away from the hard stop 108. As describedfurther herein, this enables the needle 116 and the cannula 118 to bothbe driven in a first direction to pierce a skin of a user and then tohave the needle 116 be retracted out of the user in a second direction,leaving only the cannula 118 coupled to the user.

FIG. 3 also shows the open center area of the rail 102. In particular,FIG. 3 shows a portion of the hard stop 108 extending into the opencenter of the rail 102 and the spring 110 coupled to the hard stop 108.The slide insert 104 and slide retract 106 can include top portions thatrest and can slide along rails 302. In various embodiments, the railcomponent 102 can be considered to be a housing that is generallyrectangularly-shaped with an open center area. The perimeter of thesides of the open center area can include rails 302 (positioned oneither side of the open center area) that the slide insert 104 and theslide retract 106 can rest on and slide along. The rails 302 can belowered portions of the side walls of the rail component 102 as shownthat provides a pathway of movement while allowing the side walls of therail component 102 to stabilize the slide insert 104 and the slideretract 106.

FIG. 4 illustrates a first side view of the needle mechanism module 100.FIG. 4 illustrates a needle mechanism module lock 402 relative to thelock 120 (the lock 120 can be considered to be a needle mechanism moduleinsert lock). A first end 404 of the needle mechanism module lock 402can be coupled to or positioned against or adjacent to the lock 120. Theneedle mechanism module lock 402 can prevent the lock 120 from moving.Consequently, the needle mechanism module lock 402 and the lock 120 canprevent the release of the slide insert 104 such that the slide insert104 and the coupled slide retract 106 are prevented from moving towardthe hard stop 108.

A second end 406 of the needle mechanism module lock 402 can be engagedto move the needle mechanism module lock 402. In various embodiments,the needle mechanism module lock 402 can rotate or pivot about a pivotpoint 408 when the second end 406 is pushed in a downward direction(e.g., relative to the needle mechanism module 100 depicted in FIG. 4).The second end 406 of the needle mechanism module lock 402 can be pushedin a downward direction by a purely mechanical mechanism or anelectromechanical mechanism. In various embodiments, a user of the drugdelivery device can press a button to activate the drug delivery devicewith the second end 406 being pushed down in response thereto (e.g., thesecond end 406 can be coupled to the button). In turn, the first end 404can move upward in response by pivoting about the point 408 as describedfurther herein.

In various embodiments, a user of the drug delivery device and/or theneedle mechanism module 100 can engage a user interface component toinitiate activation of the needle mechanism module 100. The userinterface component can be any type of component or mechanism forinitiating an action based on user input including a button, a slide, atouchscreen, a dial, a knob, or a switch.

FIG. 5 illustrates the side view of the of the needle mechanism module100 as depicted in FIG. 4 without the needle mechanism module lock 402to further show the arrangement of the constituent components of theneedle mechanism module 100. FIG. 5 shows the arrangement of the lock102 relative to the rail 102 and the slide insert 104. FIGS. 1-5 depictthe needle mechanism module 100 in an initial or pre-activation state.As can be seen, the needle 116 extends beyond the cannula 118 at an endof the needle mechanism module 100 near the hard stop 108. Further, theslide insert 104 and the slide retract 106 are positioned at theopposite end of the rail component 102.

FIG. 6 illustrates release of the lock 120. FIG. 6 illustratesengagement of the of the needle mechanism module lock 402 relative tothe side view of the needle mechanism module 100 as depicted in FIG. 4.As shown in FIG. 6, indicator 602 represents a downward movement of thesecond end 406 of the needle mechanism module lock 402. The second end406 of the needle mechanism module lock 402 can be moved downward, forexample, in response to the user pressing a button to activate the drugdelivery device and/or the needle mechanism module 100. In response tothe downward movement 602 of the second end 406 of the needle mechanismmodule lock 402, the first end 404 of the needle mechanism module lock402 rotates upward about pivot 408. Indicator 604 illustrates a movementof the first end 404 of the needle mechanism module lock 402 in responseto the downward movement 602 of the first end 404.

Movement of the needle mechanism module lock 402 as shown in FIG. 6decouples the needle mechanism module lock 402 from the lock 120. Inparticular, the first end 404 of the needle mechanism module lock 402 isno longer adjacent to or positioned against the lock 120. As a result,the first end 404 of the needle mechanism module lock 402 no longerrestricts movement of the lock 120. Accordingly, the lock 120 can beallowed to move. In various embodiments, the lock 120 can rotate (e.g.,rotate counter-clockwise) as shown by indicator 606. This movement—asrepresented by indicator 606—can represent releasing the lock 120.

After movement of the lock 120, the slide insert 104 (and the coupledslide retract 106) can be free to move—for example, toward the hard stop108 as described further herein and as shown in FIG. 6. FIG. 6 canrepresent the needle mechanism module 100 during initialactivation—e.g., when a user first engages a button to fire or activatethe needle mechanism module 100 and the slide insert 104 and the slideretract 106 first move toward the hard stop 108. For example, as shownin FIG. 6, the slide insert 104 and the slide retract 106 have advancedtoward the hard stop 108 from the opposite end of the rail 102.

FIG. 7 illustrates the side view of the of the needle mechanism module100 as depicted in FIG. 6 without the needle mechanism module lock 402to further show the arrangement of the constituent components of theneedle mechanism module 100. FIG. 7 shows the lock 120 as moved orrotated (e.g., in an unlocked or released position or state) afterrestriction of the movement of the lock 120 has been removed andrelative to the initial position or state of the lock as depicted in,for example, FIG. 5. FIGS. 6 and 7 illustrate the needle mechanismmodule 100 during activation—e.g., when the lock 120 is released toenable movement of the slide insert 104 and the slide retract 106 towardthe hard stop 108.

FIG. 8 illustrates further activation of the needle mechanism module100. In particular, FIG. 8 shows the needle mechanism module 100 as theslide insert 104 and the slide retract 106 as a coupled unit initialmoves toward the hard stop 108 by action of the insertion spring 110.Indicator 802 shows a direction of movement of the slide insert 104 andthe slide retract 106 relative to their initial positions. Indicator 802also shows the direction of movement of the needle 116 an the cannula118.

As shown in FIG. 8, the slide insert 104 and the slide retract 106 arepositioned closer to the hard stop 108 relative to the positioning ofthe slide insert 104 and the slide react 106 as shown in FIG. 1. Thecoils of the insert spring 110 are shown to be closer together as theinsert spring 108 exerts a force to draw the slide insert 104 to thehard stop 108. The needle 116 and the cannula 118 move with the slideinsert 104. As a result, the needle 116 can be moved toward the user andcan be inserted into the patient. FIG. 8 can represent a partialinsertion of the needle 116 and can also represent partial insertion ofthe cannula 118.

The slide insert 104 and the slide retract 106 can continue moving inthe direction 802 until the slide insert 104 meets the hard stop 108. Inparticular, the slide insert 104 can continue moving in the direction802 until the end of the tension lock component 114 is positionedadjacent to the hard stop 108. During the movement of the slide insert104 toward the hard stop 108, a portion of the needle 116 can be furtherinserted into the patient (along with a portion of the cannula 118).FIG. 8 shows a cross-sectional side view of the needle mechanism module100.

FIG. 9 illustrates the needle mechanism module 100 with the needle 116fully inserted into the patient (e.g., inserted to a maximum depth or bya maximum amount). As shown in FIG. 9, a front portion or first end 902of the tension lock 114 is positioned against the hard stop 108.Accordingly, the hard stop 108 prevents any further movement of theslide insert 104 when the first end 902 is so positioned. The movementof the slide insert 104 from its initial position (e.g., as shown inFIG. 1) to the position where the tension lock 114 is positioned againstthe hard stop 108 (e.g., as shown in FIG. 9) can determine the fullyinserted position of the needle 116. FIG. 9 also illustrates across-sectional side view of the needle mechanism module 100.

When the tension lock 114 is positioned against the hard stop 108 asshown in FIG. 9, a second end or back portion 904 of the tension lock114 can extend beyond the rail beam 126. When the back portion 904 ofthe tension lock 114 extends beyond the beam 126, the tension lock 114is able to deflect downwards as shown by indicator 906. Further, theslide retract 106 can include an angled portion 908 in proximity to theinterface of the slide retract 106 and the tension lock 114. The angledportion 908 at this interface can cause or help the tension lock 114 tobe pushed or deflected downward based on a force provide by the retractspring 112.

In particular, the retract spring 112 can be biased to push the sideinsert 104 and the slide retract 106 apart but can be prevented fromdoing so while the tension lock component 114 is positioned over and/oradjacent to the rail beam 126. When the tension lock component 114 movesfar enough toward the hard stop 108 to no longer be positioned over therail beam 126, the tension lock component 114 may no longer function tokeep the slide insert 104 and the slide retract 106 coupled together asdescribed herein. FIG. 9 can represent the needle mechanism module 100when the needle 116 is fully inserted into the patient and just prior toretraction of the needle 116.

FIG. 10 illustrates the needle mechanism module 100 during an initialstage of retraction of the needle 116. As shown in FIG. 10, the tensionlock 114 is deflected downward (e.g., relative to the position of thetension lock 114 as shown in FIG. 9). Prior to being deflected downward,the tension lock 114 retains the slide retract 106 against the slideinsert 104. When the back portion 904 of the tension lock 114 is nolonger over top of the rail beam 126, the rail beam 126 no longerrestricts the downward movement of the tension lock 114. When thetension lock 114 moves downward, the slide retract 106 is capable ofbeing removed from or decoupled from the slide insert 104 by a movementor force of the retract spring 112. In various embodiments, the spring112 can begin to expand to force the tension lock portion 904 downwardas the spring 112 begins to push the slide retract away from the hardstop 108 and the slide insert 104. FIG. 10 illustrates the needlemechanism module 100 just prior to the slide retract 106 moving awayfrom the slide insert 104 (e.g., in a direction away from the hard stop108). Further, FIG. 10 can represent an operation state of the needlemechanism module 100 with the cannula 118 inserted into the patient oruser.

FIG. 11 illustrates the needle mechanism module 100 during retraction.Specifically, FIG. 11 illustrates the needle mechanism module 100 duringa partially retracted state of the needle 116 relative to the positionof the needle 116 as shown in FIG. 9. As shown in FIG. 11, the slideretract 106 is moving away from the needle insert 104 in a direction1102. The expansion of the retract spring 112 can cause the slideretract 106 to move in the direction 1102 relative to the stationaryslide insert 104 which remains positioned against the hard stop 108. Asshown in FIG. 11, the needle 116 is retracted inside of the cannula 118(e.g., as it moves in the direction 1102 with the slide retract 106)while the cannula 118 remains stationary (and coupled to the slideinsert 104). As a result of the movement of the slide retract 106 andthe needle 116 coupled thereto, the needle 116 can be removed from thepatient and the cannula 118 can remain inside of the patient,maintaining the fluid path component from the stored liquid drug to thepatient. The slide retract 106 can continue moving in the direction 1102until the retract spring 112 is expanded further.

FIG. 12 illustrates the needle mechanism module 100 when the needle 116is fully retracted. As shown in FIG. 12, the retraction spring 110 ismore fully expanded. The slide retract 106 is positioned at its furthestdistance away from the slide insert 104. For example, the slide retract106 can be positioned at a far end of the rail 102 opposite the end ofthe rail 102 coupled to the hard stop 108. The needle 116 has retractedfurther inside of the cannula 118 relative to the position of the needle116 as depicted in FIG. 11. Meanwhile, the cannula 118 remainsstationary and can be left inserted into the patient.

FIG. 12 can represent the needle mechanism module 100 after completionof the retraction of the needle 116. The stored liquid drug can beprovided to the patient by the fluid path component that can include theneedle 116 and the cannula 118. A portion of the end of the cannula 118that extends beyond the end of the needle 116 can be positioned withinthe patient.

FIG. 13 illustrates an overhead side view of the needle mechanism module100 as depicted in FIG. 12. FIG. 13 illustrates the arrangement andpositioning of the needle insert 104 and the needle retract 106 afterretraction of the needle 116 is completed. As shown in FIG. 13, acomplete fluid path is provided to the patient through coupling of theneedle 116 to a stored liquid drug, the coupling of the needle 116 tothe cannula 118, and the coupling the cannula 118 to the patient. Theslide insert 104 is positioned against the hard stop 108 at a first endof the rail 102. The slide retract 106 is positioned at an opposite endof the rail 102. The retract spring 112 can maintain the separation ofthe slide insert 104 and the slide retract 106 as shown in FIG. 13.

FIG. 14 illustrates a close-up view of the hard stop 108. As shown inFIG. 14, the hard stop 108 can include a first portion 1402 and a secondportion 1404. The first portion 1402 can extend from the second portion1404. The second portion 1404 can be a base portion. The first portion1402 can be a cylindrically-shaped portion that extends from the secondportion 1404. As further shown in FIG. 14, the first portion 1402 caninclude one or more components 1406 positioned along the first portion1402. The components 1406 can extend radially from the first portion1402. The components 1406 can be used to hold or retain an end of theinsert spring 110. The base portion 1404 can be coupled to an end of therail 102. The first portion 1402 can extend into the open area of therail 102.

FIG. 15 illustrates a close-up view of the slide insert 104. As shown inFIG. 15, the slide insert 104 can include a first portion 1502 and asecond portion 1504. The first portion 1502 can extend from the secondportion 1504. The second portion 1504 can be a base portion. The firstportion 1502 can be a cylindrically-shaped portion that extends from thesecond portion 1504. As further shown in FIG. 15, the first portion 1502can include one or more components 1506 positioned along the firstportion 1502. The components 1506 can extend radially from the firstportion 1502. The components 1506 can be used to hold or retain an endof the insert spring 110 (e.g., an end opposite the end of the insertspring 110 that is held in place by the components 1406 depicted in FIG.14).

The slide insert 104 can further include a top portion 1508. The pocketor opening 122 can be positioned on a top side of the top portion 1508.An underside of the top portion 1508 can rest and move along the rails302 of the rail base component 102. The pocket 122 can include a channelor opening allowing the needle 116 and cannula 118 to be positionedwithin it for stability.

FIGS. 16-18 shows various views of the arrangement of the slide insert104 and the slide retract 106 relative to the lock 120. FIG. 16 shows afront view of the slide insert 104, slide retract 106, and the lock 120.FIG. 17 shows a side view of the slide insert 104, slide retract 106,and the lock 120. FIG. 18 shows a view of the of the slide insert 104,slide retract 106, and the lock 120 at an angle—e.g., an angle betweenthe views shown in FIGS. 16 and 17. FIGS. 16-18 show the lock 120 in aninitial locked position.

As shown in FIGS. 16-18, the lock 120 can include interior raisedcomponents 1602. The components 1602 can restrict movement of the slideinsert 104. Prior to the lock 102 being rotated as described above, thecomponents 1602 can be positioned against a portion of the slide insert104 and can restrict the movement of the slide insert 104. Once the lock120 is rotated, the components 1602 can be moved away from and out ofcontact with the slide insert 104. As a result, the slide insert 104 isno longer restricted from moving, enabling the needle 116 of the needlemechanism module 100 to be inserted as described above.

FIG. 19 illustrates an exemplary method of operation 1900 for insertinga needle into a patient and then retracting the needle from the patientwhile maintaining a cannula coupled to the patient. The method ofoperation 1900 can be implemented by the needle mechanism module 100.

At 1902, a lock 120 of the needle mechanism module 100 can be released.The lock 120 can be released in any number of manners. In variousembodiments, the lock 120 can be released by engaging a needle mechanismmodule lock 402. The needle mechanism module lock 402 can be engageddirectly by a user or indirectly by a user. For example, the mechanismmodule lock 402 can respond to mechanical or electrical engagement by auser pressing a button. Releasing the lock 120 can no longer restrictmovement of a slide insert 104 and a slide retract 106.

At 1904, the slide insert 104 and the slide retract 106 can be driventoward the patient. A spring 110 coupled to a hard stop 108 and coupledto the slide insert 104 can be biased to bring the slide insert 104toward the hard stop 108 once the lock 102 is released. The slideretract 106 can be coupled to the slide insert 104 so as to move towardthe hard stop 108 when the lock 102 is released. The hard stop 108 canbe attached to a far end of a rail housing component 102, opposite anend from which the slide insert 104 and the slide retract 106 areinitially positioned.

A needle 116 and a cannula 118 can be coupled to the slide insert 104and can both be advanced toward the patient as the slide insert 104 isadvanced toward the hard stop 108. The movement of the needle 116 andthe cannula 118 toward the patient can eventually cause the needle 116to pierce the patient, allowing the needle 116 and/or the cannula 118 toenter the patient.

At 1906, the slide insert 104 can reach the hard stop 108. When theslide insert 104 reaches the hard stop 108, the needle 116 and thecannula 118 are prevented from further entering the patient.Accordingly, a maximum insertion depth of the needle 116 and/or thecannula 118 can be reached. Further, when the slide insert 104 reachesthe hard stop 108, a tension lock component 114 can extend beyond a railbeam 126. The tension lock component 114 can maintain a coupling orattachment between the slide insert 104 and the slide retract 106 aslong as the rail beam 126 is positioned adjacent to the tension lockcomponent 114. The rail beam 126 can be stationary while the tensionlock component 114 can be coupled to the slide insert 104 and the slideretract 106. Accordingly, as the slide insert 104 and the slide retract106 move toward the hard stop 108, the tension lock component 114 movesalong the rail beam 126. Eventually, when the slide inset 104 reachesthe hard stop 108, the tension lock component 114 can move beyond therail beam 126, such that the tension lock component 114 and the railbeam component 126 are no longer overlapping or adjacent to one another.

At 1908, since the tension lock component 114 no longer overlaps thestationary rail beam 126, the tension lock component 114 can be bentdownward in response to expansion of a spring 112. The spring 112 can becoupled between the slide insert 104 and the slide retract 106. Thespring 112 can be prevented from expanding when the tension lockcomponent 114 is not able to be bent or deflected downwards, therebyensuring the slide insert 104 and the slide retract 106 are maintainedin close proximity or coupled closely together. Once the tension lockcomponent 114 clears the rail beam 126 and is free to be deflecteddownwards, the spring 112 can expand. As the spring 112 expands, thespring 112 can force the slide retract 106 to move away from the slideinsert 104. In particular, the slide insert 104 can remain stationaryand pressed against the hard stop 108 as the slide retract moves backtoward the opposite end of the rail housing component 102.

The movement of the slide retract 106 away from the hard stop 108 canretract the needle 116. The needle 116 can be retracted out of thepatient. The cannula 118 can remain coupled inside of the patient as itis coupled to the slide insert 104. Accordingly, at 1908, the needle 116can be retracted from the patient without disturbing the positioning ofthe cannula 118 which is inserted into the patient at 1906.

At 1910, the slide retract 106 can reach the far end of the rail housingcomponent 102. The needle 116 can be fully retracted from the user whilethe slide insert 104 and the cannula 118 remain stationary, with thecannula 118 remaining inserted into the user.

The following examples pertain to further embodiments:

Example 1 is a needle mechanism module comprising a rail housingcomponent, a slide insert component coupled to the rail housingcomponent and configured to slide along the rail housing component, aslide retract component coupled to the rail housing component andconfigured to slide along the rail housing component, a hard stopcomponent coupled to a first end of the rail housing component, theslide insert component and the slide retract component positioned towarda second, opposite end of the rail housing component, the slide insertcomponent positioned closer to the hard stop component, an insertextension spring coupled to the hard stop component and to the slideinsert component, a retract compression spring positioned between theslide insert component and the slide retract component, a tension lockcomponent positioned through the slide insert component and the slideretract component and configured to couple the slide insert component tothe slide retract component, an insert lock positioned against the slideinsert component and configured to restrict movement of the slide insertcomponent and the slide retract component toward the hard stop by theinsert spring, a needle coupled to the slide insert component and theslide retract component, the needle further coupled to a liquid drugstored in a reservoir of a wearable drug delivery device, and a cannulasurrounding a portion of the needle extending from the slide insertcomponent, an end of the cannula coupled to the slide insert component.

Example 2 is an extension of Example 1 or any other example disclosedherein, further comprising a needle mechanism module lock coupled to theinsert lock, the needle mechanism module lock configured to restrictmovement of the insert lock.

Example 3 is an extension of Example 2 or any other example disclosedherein, wherein the needle mechanism module lock is coupled to a pushbutton.

Example 4 is an extension of Example 3 or any other example disclosedherein, wherein the needle mechanism module is configured to remain inan idle state until a user engages the push button.

Example 5 is an extension of Example 4 or any other example disclosedherein, wherein the needle mechanism module lock is configured to allowmovement of the insert lock responsive to the user engaging the pushbutton.

Example 6 is an extension of Example 5 or any other example disclosedherein, wherein the insert lock is configured to rotate when allowed tomove and to allow movement of the slide insert component and the slideretract component.

Example 7 is an extension of Example 6 or any other example disclosedherein, wherein the slide insert component and the slide retractcomponent are configured to move along the rail housing component towardthe hard stop component when allowed to move based on a force providedby the insert extension spring.

Example 8 is an extension of Example 7 or any other example disclosedherein, wherein the needle and the cannula are configured to move withthe slide insert component and the slide retract component and areconfigured to be inserted into the user as the slide insert componentand the slide retract component move toward the hard stop component.

Example 9 is an extension of Example 8 or any other example disclosedherein, wherein when the tension lock component meets the hard stopcomponent, an end of the tension lock component positioned furthest fromthe hard stop component is configured to deflect downward to enable theretract compression spring to expand, wherein prior to the tension lockcomponent meeting the hard stop component, a rail beam of the railhousing component is configured to prevent the end of the tension lockcomponent from deflecting downward.

Example 10 is an extension of Example 9 or any other example disclosedherein, wherein the needle is inserted into the user by a maximum amountwhen the tension lock component meets the hard stop component.

Example 11 is an extension of Example 10 or any other example disclosedherein, wherein the slide insert component and the cannula remainstationary and the slide retract component and the needle retract awayfrom the hard stop component toward the second end of the rail housingcomponent as the retract compression spring expands, thereby removingthe needle from the user and leaving the cannula in the user.

Example 22 is a method comprising releasing a lock component, driving aslide insert component and a slide retract component in a firstdirection from a first end of a rail housing component to a second,opposite end of the rail housing component, inserting a needle and acannula into a user as the slide insert component is driven toward thesecond end of the rail housing component, the needle and the cannulacoupled to the slide insert component, deflecting a tension lockcomponent downward to allow a retract compression spring positionedbetween the slide insert component and the slide retract component toexpand, driving the slide retract component in a second, oppositedirection from the second end of the rail toward the first end of therail, and removing the needle from the user while the cannula remainsinserted in the user.

Example 13 is an extension of Example 12 or any other example disclosedherein, further comprising restricting movement of the slide insertcomponent and the slide retract component toward the second end of therail housing component prior to releasing the lock component.

Example 14 is an extension of Example 13 or any other example disclosedherein, further comprising releasing the lock component in response tothe user engaging a user interface component.

Example 15 is an extension of Example 14 or any other example disclosedherein, further comprising rotating the lock component in response tothe user engaging the user interface component to allow movement of theslide insert component and the slide retract component toward the secondend of the rail housing component.

Example 16 is an extension of Example 15 or any other example disclosedherein, further comprising driving the slide insert component and theslide retract component in the first direction by retraction of anextension spring positioned between a hard stop component and the slideinsert component, the hard stop component coupled to the second end ofthe rail housing component.

Example 17 is an extension of Example 16 or any other example disclosedherein, further comprising coupling the slide insert component to theslide retract component by the tension lock component prior to the slideinsert component reaching the second end of the rail housing component.

Example 18 is an extension of Example 17 or any other example disclosedherein, further comprising preventing the tension lock component fromdeflecting downward prior to the slide insert component reaching thesecond end of the rail housing component.

Example 19 is an extension of Example 18 or any other example disclosedherein, further comprising driving the slide retract component in thesecond, opposite direction from the second end of the rail toward thefirst end of the rail by a compression spring allowed to expand by thetension lock component deflecting downward.

Example 20 is an extension of Example 19 or any other example disclosedherein, further comprising restricting movement of the slide insertcomponent and the cannula coupled to the slide insert component as theslide retract component and the needle move toward the first end of therail housing component.

Certain embodiments of the present invention were described above. Itis, however, expressly noted that the present invention is not limitedto those embodiments, but rather the intention is that additions andmodifications to what was expressly described herein are also includedwithin the scope of the invention. Moreover, it is to be understood thatthe features of the various embodiments described herein were notmutually exclusive and can exist in various combinations andpermutations, even if such combinations or permutations were not madeexpress herein, without departing from the spirit and scope of theinvention. In fact, variations, modifications, and other implementationsof what was described herein will occur to those of ordinary skill inthe art without departing from the spirit and the scope of theinvention. As such, the invention is not to be defined only by thepreceding illustrative description.

1. A needle mechanism module, comprising: a rail housing component; aslide insert component coupled to the rail housing component andconfigured to slide along the rail housing component; a slide retractcomponent coupled to the rail housing component and configured to slidealong the rail housing component; a hard stop component coupled to afirst end of the rail housing component, the slide insert component andthe slide retract component positioned toward a second, opposite end ofthe rail housing component; an insert extension spring coupled to thehard stop component and to the slide insert component; a retractcompression spring positioned within the insertion extension spring andbetween the slide insert component and the slide retract component; anda needle coupled to the slide insert component and the slide retractcomponent, the needle further coupled to a liquid drug stored in areservoir of a wearable drug delivery device.
 2. The needle mechanismmodule of claim 1, further comprising: a needle mechanism module lockcoupled to an insert lock, wherein the insert lock is positioned againstthe slide insert component, and the needle mechanism module lock isconfigured to restrict movement of the insert lock.
 3. The needlemechanism module of claim 2, wherein the needle mechanism module lock iscoupled to a push button.
 4. The needle mechanism module of claim 3,wherein the needle mechanism module is configured to remain in an idlestate until engagement of the push button.
 5. The needle mechanismmodule of claim 2, wherein the needle mechanism module lock isconfigured to allow movement of the insert lock responsive to theengagement of the push button.
 6. The needle mechanism module of claim2, wherein the insert lock is configured to rotate when allowed to moveand to allow movement of the slide insert component and the slideretract component.
 7. The needle mechanism module of claim 1, whereinthe slide insert component and the slide retract component areconfigured to move along the rail housing component toward the hard stopcomponent when allowed to move based on a force provided by the insertextension spring.
 8. The needle mechanism module of claim 7, furthercomprising: a cannula surrounding a portion of the needle extending fromthe slide insert component, an end of the cannula coupled to the slideinsert component, wherein the needle and the cannula are configured tomove with the slide insert component and the slide retract component andare configured to be inserted into the user as the slide insertcomponent and the slide retract component move toward the hard stopcomponent.
 9. The needle mechanism module of claim 1, furthercomprising: a tension lock component positioned through the slide insertcomponent and the slide retract component and configured to couple theslide insert component to the slide retract component, wherein when thetension lock component meets the hard stop component, an end of thetension lock component positioned furthest from the hard stop componentis configured to deflect downward to enable the retract compressionspring to expand, wherein prior to the tension lock component meetingthe hard stop component, a rail beam of the rail housing component isconfigured to prevent the end of the tension lock component fromdeflecting downward.
 10. The needle mechanism of claim 9, wherein theneedle is inserted into a user by a maximum amount when the tension lockcomponent meets the hard stop component.
 11. The needle mechanism moduleof claim 10, further comprising: a cannula surrounding a portion of theneedle extending from the slide insert component, an end of the cannulacoupled to the slide insert component, wherein the slide insertcomponent and the cannula remain stationary and the slide retractcomponent and the needle retract away from the hard stop componenttoward the second end of the rail housing component as the retractcompression spring expands, thereby removing the needle from the userand leaving the cannula in the user.
 12. The needle mechanism module ofclaim 11, wherein, when the needle is fully retracted, the slide retractcomponent is positioned at its furthest distance away from the slideinsert component.
 13. The needle mechanism module of claim 1, wherein,in a retracted state, the needle mechanism module has a configuration inwhich: the slide insert component is positioned against the hard stopcomponent at a first end of the rail, the slide retract component ispositioned at an opposite end of the rail housing component, and theretract compression spring maintains a separation between the slideinsert component and the slide retract component.
 14. The needlemechanism module of claim 1, wherein the hard stop component includes: afirst portion; and a second portion from which the first portionextends; wherein: the first portion is cylindrical and includes holdingcomponents configured to retain an end of the insert extension spring;and the second portion is coupled to an end of the rail housingcomponent.
 15. The needle mechanism module of claim 1, wherein the slideinsert component further comprises: a top portion having a top side andan underside, wherein a pocket is formed in the top side and theunderside rests on and moves along the rail housing component.
 16. Theneedle mechanism module of claim 15, wherein the pocket includes achannel within which the needle is positioned.
 17. The needle mechanismmodule of claim 1, further comprising: a lock configured to rotate andrestrict movement of the slide insert component when in an initiallocked position, wherein the lock includes an interior raised componentconfigured to restrict the movement of the slide insert component whenpositioned against a portion of the slide insert in the initial lockedposition.
 18. The needle mechanism module of claim 17, wherein: the lockis configured, when rotated from the initial locked position, theinterior raised component is moved away from and out of contact with theslide insert component.